市场调查报告书
商品编码
1559469
医疗保健实验·检验·认证 (TIC):市场洞察·竞争环境·市场预测 (~2030年)Healthcare Testing, Inspection, and Certification (TIC) - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
在 2024 年至 2030 年的预测期内,医疗保健测试、检验和认证 (TIC) 市场规模预计将以 8.1% 的复合年增长率增长。
产品召回的增加促使对 TIC 服务的需求大幅增加。数位健康和医疗设备的日益普及也进一步支持了市场扩张。此外,製药公司和医疗器材製造商增加了对新药和医疗器材开发的研发活动和投资,需要严格的 TIC 才能获得产品批准。这些动态有助于预测期内市场的强劲成长。
产品风险评估、品质测试和认证服务对于製药和医疗器材公司减少产品召回至关重要。医疗保健 TIC 服务帮助製药和医疗器材公司识别潜在的产品缺陷和製造过程的不一致。例如,根据美国食品药物管理局(USFDA)2023年6月发布的《2022年药品品质状况报告》,2022年有166家机构报告了912起召回事件,为过去五年来的最高数量。 CGMP 问题、储存温度偏差和辅料污染是这些召回的主要原因。医疗保健 TIC 在找出这些问题以维持产品品质并最大程度地减少产品召回的可能性方面发挥关键作用。
根据世界卫生组织(WHO)2022年发布的数据,全球医疗器材种类超过200万种,分为7,000多个通用器材组。医疗设备的增加是由于医疗设备用于疾病的诊断、治疗和预防的使用增加。医疗器材 TIC 服务在识别和纠正营运问题、确保遵守监管标准、推动市场成长方面发挥关键作用。
本报告提供全球医疗保健实验·检验·认证 (TIC) 的市场调查,彙整市场概要,市场影响因素及市场机会分析,法律制度,市场规模的转变·预测,各种区分·地区/各主要国家的详细分析,竞争情形,主要企业简介等资讯。
Healthcare Testing, Inspection, and Certification (TIC) Market by Sourcing Type (In House, Outsourced), Service Type (Testing, Inspection, Certification), End-Users (Pharma and Biotechnology Companies, Medical Technology Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2030 owing to the surge in demand for medical devices testing and growing adoption of digital health & medical devices
The Healthcare Testing, Inspection, and Certification (TIC) market is estimated to grow at a CAGR of 8.1% during the forecast period from 2024 to 2030. The healthcare testing, inspection, and certification (TIC) market is poised for significant growth from 2024 to 2030, driven by several key factors. A notable surge in demand for TIC services stems from the increasing number of product recalls. The expanding adoption of digital health and medical devices further fuels market expansion. Additionally, rising R&D activities and investments by pharmaceutical and MedTech companies in developing novel drugs and devices necessitate rigorous testing, inspection, and certification to achieve product approval. These dynamics collectively contribute to the robust growth forecast for the healthcare TIC market during the forecast period.
Healthcare Testing, Inspection, And Certification (TIC) Market Dynamics:
Product risk assessment, quality testing, and certification services are crucial for pharmaceutical and medical device companies in reducing product recalls. Healthcare testing, inspection, and certification (TIC) services assist pharmaceutical and medical device firms in identifying potential product defects and inconsistencies in manufacturing processes. For example, according to the State of Pharmaceutical Quality Report 2022 published by the United States Food and Drug Administration (USFDA) in June 2023, a total of 166 sites reported 912 recalls in fiscal year 2022, the highest in five years. Consistently, CGMP issues, storage temperature deviations, and excipient contaminations were the primary reasons for these recalls. Healthcare TIC plays a vital role in pinpointing these issues to uphold product quality and minimize the likelihood of product recalls.
According to data published by the World Health Organization (WHO) in 2022, it was estimated that there were more than two million different types of medical devices in the world which were categorized in more than 7000 generic device groups. This growth in medical devices is attributed to the growing use of medical devices for diagnoses, treatment, and prevention of diseases. Testing, inspection, and certification services in medical devices play a crucial role in identifying and rectifying operational issues to ensure compliance with regulatory standards, thereby stimulating market growth.
According to data published by the Office of the National Coordinator for Health Information Technology in April 2022, approximately 78% of office-based physicians and 96% of non-federal acute care hospitals had implemented certified Electronic Health Records (EHRs), in 2021, which a part of digital health tools. This represents a significant advancement over the past decade, as compared to 2011 when only 34% of physicians and 28% of hospitals had adopted EHR systems. Therefore, the rising adoption of digital health solutions such as HER is estimated to propel the growth of the healthcare TIC market.
The pharmaceutical industry report published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2023 revealed significant investment trends. In 2020, the industry invested USD 42,779.87 million (EUR 39,442 million), followed by USD 46,132.45 million (EUR 42,533 million) in 2021. By 2022, this investment had risen to USD 48,264.82 million (EUR 44,500 million), indicating a steady increase over the years. Due to increased R&D activities and investments, there is a growing demand for drug quality testing, inspection, and certification services, which is consequently contributing to the expansion of the market.
However, the high cost associated with TIC service, and the stringent regulatory standards and guidelines, among others are some of the key constraints that may limit the growth of the healthcare testing, inspection, and certification (TIC) market.
Healthcare Testing, Inspection, And Certification (TIC) Market Segment Analysis:
Healthcare Testing, Inspection, and Certification (TIC) Market by Sourcing Type (In House, Outsourced), Service Type (Testing, Inspection, Certification), End-Users (Pharma and Biotechnology Companies, Medical Technology Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the service type segment of the healthcare testing, inspection, and certification (TIC) market, the testing category was estimated to amass the largest revenue share in 2023. Medical device testing offers numerous advantages, including enhancing patient safety, ensuring compliance with legal and regulatory standards, safeguarding device and patient data against breaches, and optimizing cost management. For manufacturers in the medical device industry, maintaining quality, assurance, and transparency is paramount. These are the factors contributing to the growth of the segment in the healthcare testing, inspection, and certification (TIC) market.
In December 2023, TUV SUD, a prominent Germany-based certification, testing, auditing, inspection, and training company, inaugurated its state-of-the-art testing and inspection laboratory in Bangalore. This facility offers comprehensive testing services for active medical devices, in vitro diagnostic devices, non-active medical devices, and other electrical components. These testing services are performed to assess medical device biocompatibility testing, toxicity assessment, and microbiology testing.
In pharmaceutical drug development, rigorous testing is essential across all phases of research, development, and manufacturing. It's imperative to optimize new formulations for stability and bioavailability to ensure effective drug delivery and treatment outcomes. Precise measurements of lead APIs, excipients, and impurities are conducted, and manufacturing processes are meticulously designed to adhere to rigorous quality control standards.
In March 2024, Element Materials Technology, a United Kingdom-based TIC company launched an innovative Rapid Response Pharmaceutical Testing Service from its Manchester Life Sciences laboratory. This innovative offering will support the pharmaceutical industry by delivering expedited and comprehensive testing solutions to pharma companies globally, meeting the demands of regulatory requirements for fast product approval.
Further, testing service supports product compliance, interaction between drugs and excipients, compatibility of medical devices, and meeting regulatory guidelines for products in development are the key benefits associated with testing service. Therefore, the various applications provided by the testing service for pharmaceuticals and medical devices are expected to foster segment growth, thereby driving the growth of the healthcare testing, inspection, and certification (TIC) market during the forecast period.
North America Is Expected To Dominate The Overall Healthcare Testing, Inspection, And Certification (TIC) Market:
North America was estimated to account for the largest market share of the healthcare testing, inspection, and certification (TIC) market in 2023. This is due to the presence of major market players engaged in drug and medical device development which requires testing, inspection, and certification, contributing to the growth of the market. Additionally, growing healthcare spending and developed healthcare infrastructure in the region are some of the key factors driving the growth of the healthcare testing, inspection, and certification (TIC) market in North America.
The escalating healthcare expenditure is driving the need for advanced medical devices tailored for patients grappling with chronic diseases. This increasing demand necessitates thorough testing and inspection of devices to meet regulatory standards, consequently fostering market growth in the region. In June 2021, according to a report published by the Advanced Medical Technology Association, a United States-based medical device trade association, expenditures on medical and in-vitro diagnostics amounted to $199.1 billion, comprising 5.2 percent of total national health expenditures in 2019. In 2021, according to the Centers for Medicare and Medicaid Services, a United States-based federal agency, anticipate that annual healthcare spending on medical devices in the United States is expected to rise from approximately $300 billion in 2021 to $400 billion by 2030. This represents around 5-6% of the projected $6.8 trillion total healthcare expenditure.
In 2021, TUV SUD, a Germany-based testing and certification company, has recently been admitted to the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. This program focuses on ensuring the safety and performance testing of medical devices. With its accreditation, TUV SUD's North American labs are now authorized to conduct premarket testing for device manufacturers aiming to enter the U.S. market.
Moreover, significant players in the region are strategically focusing on maintaining their market presence by acquiring smaller entities. For instance, in 2021, NAMSA, a company based in the United States, announced the successful acquisition of American Preclinical Services (APS) for an undisclosed amount. This acquisition enhances NAMSA's position in the medical device testing sector, leveraging APS's expertise in medical device development and preclinical research.
Healthcare Testing, Inspection, And Certification (TIC) Market Key Players:
Some of the key market players operating in the healthcare testing, inspection, and certification (TIC) market include SGS Societe Generale de Surveillance SA, DEKRA, Intertek Group plc, Nemko, Smithers, Eurofins Scientific, UL LLC, TUV SUD, Element Materials Technology, CSA Group Testing & Certification Inc., ALS, Applus+, Bureau Veritas, DeviceLab Inc., DNV GL, EdgeOne Medical Inc., F2 Labs, North American Science Associates, LLC, UX Firm, Neva Analytics, and others.
Recent Developmental Activities In The Healthcare Testing, Inspection, And Certification (TIC) Market:
Key Takeaways From The Healthcare Testing, Inspection, And Certification (TIC) Market Report Study
Target Audience Who Can Be Benefited From This Healthcare Testing, Inspection, And Certification (TIC) Market Report Study
Frequently Asked Questions For The Healthcare Testing, Inspection, And Certification (TIC) Market:
Healthcare Testing, Inspection, And Certification (TIC) Market ensures pharmaceuticals and medical devices meet safety, efficacy, and regulatory standards. It involves thorough evaluation through chemical, physical, biological, and microbiological analyses to assess quality and performance. Inspection verifies manufacturing compliance, while certification confirms adherence to standards and regulations.
The Healthcare Testing, Inspection, and Certification (TIC) market is estimated to grow at a CAGR of 8.1% during the forecast period from 2024 to 2030.
The healthcare testing, inspection, and certification (TIC) market is poised for significant growth from 2024 to 2030, driven by several key factors. A notable surge in demand for TIC services stems from the increasing number of product recalls. The expanding adoption of digital health and medical devices further fuels market expansion. Additionally, rising R&D activities and investments by pharmaceutical and MedTech companies in developing novel drugs and devices necessitate rigorous testing, inspection, and certification to achieve product approval. These dynamics collectively contribute to the robust growth forecast for the healthcare TIC market during the forecast period.
Some of the key market players operating in the healthcare testing, inspection, and certification (TIC) include SGS Societe Generale de Surveillance SA, DEKRA, Intertek Group plc, Nemko, Smithers, Eurofins Scientific, UL LLC, TUV SUD, Element Materials Technology, CSA Group Testing & Certification Inc., ALS, Applus+, Bureau Veritas, DeviceLab Inc., DNV GL, EdgeOne Medical Inc., F2 Labs, North American Science Associates, LLC, UX Firm, Neva Analytics, and others.
North America was estimated to account for the largest market share of the healthcare testing, inspection, and certification (TIC) market in 2023. This is due to the presence of major market players engaged in drug and medical device development which requires testing, inspection, and certification, contributing to the growth of the market. Additionally, growing healthcare spending and developed healthcare infrastructure in the region are some of the key factors driving the growth of the healthcare testing, inspection, and certification (TIC) market in North America.